FDA General
Califf Agrees to Ethics Commitments to Bolster Nomination
FDA commissioner nominee Robert Califf agrees to significant ethics commitments in a move to secure Senate support for his nomination.
Biologics
Moderna Covid Vaccine Now Approved as Spikevax
FDA grants full approval to Modernas Covid-19 vaccine under the name Spikevax for use in individuals 18 years of age and older.
Human Drugs
FDA Releases 4 Guides on Real-World Data/Evidence
FDA posts four draft guidances on the use of real-world data and real-world evidence in regulatory decision-making, covering topics related to data so...
Federal Register
Combo Products Guide on Premarket Pathways
Federal Register notice: FDA makes available a final guidance entitled Principles of Premarket Pathways for Combination Products.
Federal Register
FDA Renews Vaccine Advisory Committee
Federal Register notice: FDA renews for an additional two years its Vaccines and Related Biological Products Advisory Committee.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 1/28/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Comments Extended on Device Modeling/Simulation Guide
Federal Register notice: FDA extends the comment period for a 12/23 notice on a draft guidance entitled Assessing the Credibility of Computational Mod...
Federal Register
Info Collection on FDA Communications Testing
Federal Register notice: FDA sends to OMB an information collection extension entitled Generic Clearance for Quantitative Testing for the Development ...
FDA General
House Health Subcommittee Hearing on User Fee Agreements
The House Energy and Commerce Committees Health Subcommittee announces a 2/3 user fee reauthorization hearing that will review FDA/industry agreements...
